CMV Reactivation in Acute Necrotizing Pancreatitis

NCT05898048 | Completed

• 1 other identifier: 2023-51-DM-130
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with the diagnosis of acute necrotizing pancreatitis (ANP) present with a wide spectrum of severity. These patients frequently require intensive care management. According to the revised Atlanta classification (2012), acute pancreatitis is divided into distinct subtypes, based on the presence or absence of necrosis. The mortality rates for sterile necrosis though comparatively low (5%-10%), but superinfection of the necrotic pancreas and peri-pancreatic tissue/ fluid collections increases the mortality rate considerably (up to one-third). The most common organisms isolated from the infected pancreatic necrosum are gram-negative bacteria mainly Escherichia coli and Klebsiella pneumoniae followed by gram-positive bacteria; however, with the increased use of antibiotic therapies in the ICU, the incidence of pancreatic fungal infections is also on a rise. Traditionally, critically ill patients have been considered immunocompetent but the immunomodulatory effects of sepsis may lead to reactivation of dormant viral infections. In recent years, Cytomegalovirus (CMV) reactivation in critically ill patients has been recognized with as high as 71% incidence with associated higher mortality, organ failure rates, duration of mechanical ventilation, nosocomial infections, and ICU length of stay. CMV reactivation had been studied in various cohorts in the ICU population, such as acute respiratory distress syndrome (ARDS) and septic shock exhibiting their impact on mortality. However, currently, no study is available investigating the role of CMV reactivation in patients with acute necrotizing pancreatitis. Therefore, the investigators aimed to study the prevalence of CMV reactivation and its viral load kinetics in critically ill patients with acute necrotizing pancreatitis.

Conditions

Acute Necrotizing Pancreatitis

Keywords

Critically ill; Cytomegalovirus; Reactivation; Intensive care unit

Outcome Measures

Primary Outcomes (2)

• Prevalence of Cytomegalovirus (CMV) reactivation in critically ill adult patients with acute necrotizing pancreatitis

  Percentage of included patients (CMV seropositive IgG) who had viral load \>1000/cc

  From the date of inclusion in the study until the day of discharge from the ICU or up to 10 weeks of illness, whichever came first

• Cytomegalovirus (CMV) viral load kinetics in critically ill adult patients with acute necrotizing pancreatitis

  Changes in CMV viral load count during their clinical course

  From the date of CMV reactivation until 2 weeks thereafter or the day of discharge from the ICU, whichever came first

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute necrotizing pancreatitis patients who require ICU admission

You may qualify if:

• Acute necrotizing pancreatitis patients who require ICU admission, with at least a two-week duration of illness and the presence of CMV seropositivity (Anti CMV IgG antibodies).

You may not qualify if:

• Age \< 18 years
• Expected survival \< 72 hours
• Duration of pancreatitis more than 10 weeks
• Use of antiviral agents within the last 7 days
• Known or suspected underlying immune deficiency (history of solid organ or stem cell transplantation, infection with the human immunodeficiency virus, hematological malignancy, use of immunosuppressive medication (more than 0.1mg/kg prednisone for \>3 months, more than 75mg/day prednisone for \>3 weeks or equivalent), chemotherapy /radiotherapy in the year before ICU admission and any known humeral or cellular immune deficiency
• Pregnancy
• Patients who do not consent to the study

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Department of Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

Lucknow, Uttar Pradesh, 226014, India

Location

Related Publications (30)

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MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Critical Illness

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohan Gurjar, MD, PDCC

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

• Atul Garg, MD

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 12, 2023
• Study Start: June 5, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

IN (1)